Endoscopic multiple sample bioptome

ABSTRACT

An endoscopic multiple sample bioptome includes a hollow outer member and an axially displaceable inner member extending therethrough. The proximal ends of the outer and inner members are coupled to an actuator for axially displacing one relative to the other. The distal end of the outer member is coupled to one of a cylinder having a sharp distal edge and a jaw assembly, while the distal end of the inner member is coupled to the other. The jaw assembly includes a pair of opposed, preferably toothed jaw cups each of which is coupled by a resilient arm to a base member. The arms are bent to urge the jaws away from each other. The base member is mounted inside the cylinder and axial movement of the jaw assembly and cylinder relative to each other draws the arms into the cylinder and brings the jaw cups together in a biting action. When the outer member is coupled to the jaw assembly and the inner member is coupled to the cylinder, the distal end of the inner member is preferably coupled to the cylinder by a bent end which is welded to a hole in the cylinder wall. One of the jaws is preferably larger and has a pair of proximal wings. The wings and an upper edge portion of the larger jaw are bent radially inward and enter the smaller jaw when the jaws are closed.

This application is a continuation-in-part of application Ser. No.07/837,046 filed Feb. 18, 1992, which is hereby incorporated byreference herein in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to endoscopic surgical instruments. Moreparticularly, this invention relates to an instrument for takingmultiple biopsy tissue samples.

2. State of the Art

Endoscopic biopsy procedures are typically performed with an endoscopeand an endoscopic biopsy forceps device (bioptome). The endoscope is along flexible tube carrying fiber optics and having a narrow lumenthrough which the bioptome is inserted. The bioptome typically includesa long flexible coil having a pair of opposed jaws at the distal end andmanual actuation means at the proximal end. Manipulation of theactuation means opens and closes the jaws. During a biopsy tissuesampling operation, the surgeon guides the endoscope to the biopsy sitewhile viewing the biopsy site through the fiber optics of the endoscope.The bioptome is inserted through the narrow lumen of the endoscope untilthe opposed jaws arrive at the biopsy site. While viewing the biopsysite through the fiber optics of the endoscope, the surgeon positionsthe jaws around a tissue to be sampled and manipulates the actuationmeans so that the jaws close around the tissue. A sample of the tissueis then cut and/or torn away from the biopsy site while it is trappedbetween the jaws of the bioptome. Keeping the jaws closed, the surgeonwithdraws the bioptome from the endoscope and then opens the jaws tocollect the biopsy tissue sample.

A biopsy tissue sampling procedure often requires the taking of severaltissue samples either from the same or from different biopsy sites.Unfortunately, most bioptomes are limited to taking a single tissuesample, after which the device must be withdrawn from the endoscope andthe tissue collected before the device can be used again to take asecond tissue sample. The single-sample limitation of most bioptomes isdue to the limited space between the biopsy forceps jaws. Severalattempts have been made to provide an instrument which will allow thetaking of several tissue samples before the instrument must be withdrawnand the samples collected. Problems in providing such an instrumentinclude the extremely small size required by the narrow lumen of theendoscope and the fact that the instrument must be flexible in order tobe inserted through the lumen of the endoscope. Thus, several knownmultiple sample biopsy instruments are precluded from use with anendoscope because of their size and rigidity. These include the "punchand suction type" instruments disclosed in U.S. Pat. Nos. 3,989,033 toHalpern et al. and 4,522,206 to Whipple et al. Both of these deviceshave a hollow tube with a punch at the distal end and a vacuum sourcecoupled to the proximal end. A tissue sample is cut with the punch andsuctioned away from the biopsy site through the hollow tube. It isgenerally recognized, however, that suctioning tissue samples through along narrow flexible bioptome is virtually impossible.

Efforts have been made to provide a multiple sampling ability to aninstrument which must traverse the narrow lumen of an endoscope. Theseefforts have concentrated on providing a cylindrical storage space atthe distal end of the instrument wherein several tissue samples can beaccumulated before the instrument is withdrawn from the endoscope. U.S.Pat. No. 4,651,753 to Lifton, for example, discloses a rigid cylindricalmember attached to the distal end of a first flexible tube. Thecylindrical member has a lateral opening and a concentric cylindricalknife blade is slidably mounted within the cylindrical member. A secondflexible tube, concentric to the first tube is coupled to the knifeblade for moving the knife blade relative to the lateral opening in thecylindrical member. A third flexible tube having a plunger tip ismounted within the second flexible tube and a vacuum source (a syringe)is coupled to the proximal end of the third tube. A tissue sample istaken by bringing the lateral opening of the cylindrical member upon thebiopsy site, applying vacuum with the syringe to draw tissue into thelateral opening, and pushing the second flexible tube forward to movethe knife blade across the lateral opening. A tissue sample is therebycut and trapped inside the cylindrical knife within the cylindricalmember. The third flexible tube is then pushed forward moving itsplunger end against the tissue sample and pushing it forward into acylindrical storage space at the distal end of the cylindrical member.Approximately six samples can be stored in the cylindrical member, afterwhich the instrument is withdrawn from the endoscope. A distal plug onthe cylindrical member is removed and the six samples are collected bypushing the third tube so that its plunger end ejects the samples.

The device of the Lifton patent suffers from several recognizabledrawbacks. First, it is often difficult to obtain a tissue samplelaterally of the device. Second, in order to expedite the obtaining of alateral sample, a syringe is used to help draw the tissue into thelateral opening. However, this causes what was once a two-step procedure(position and cut), to become a three-step procedure (position, suction,cut). In addition, the use of a syringe requires an additional hand.Third, the Lifton patent adds a fourth step to the biopsy procedure byrequiring that the tissue sample be pushed into the storage space. Thus,in all, the Lifton patent requires substantial effort on the part of thesurgeon and an assistant and much of this effort is involved in pushingtubes, an action which is counter-intuitive to classical biopsysampling. The preferred mode of operation of virtually all endoscopictools is that a gripping action at the distal end of the instrument iseffected by a similar action at the proximal end of the instrument.Classical biopsy forceps jaws are closed by squeezing a manual actuationmember in a syringe-like manner.

A more convenient endoscopic multiple sample biopsy device is disclosedin U.S. Pat. No. 5,171,255 to Rydell. Rydell provides a flexibleendoscopic instrument with a knife-sharp cutting cylinder at its distalend. A coaxial anvil is coupled to a pull wire and is actuated in thesame manner as conventional biopsy forceps. When the anvil is drawn intothe cylinder, tissue located between the anvil and the cylinder is cutand pushed into a storage space within the cylinder. Several samples maybe taken and held in the storage space before the device is withdrawnfrom the endoscope. While the device of Rydell is effective in providinga multiple sample tool where each sample is obtained with a traditionaltwo-step procedure (position and cut), it is still limited to lateralcutting which is often problematic. Traditional biopsy forceps providejaws which can grasp tissue frontally or laterally. Even as such, it isdifficult to position the jaws about the tissue to be sampled. Lateralsampling is even more difficult.

In addition to the biopsy procedure described above, it is alsosometimes necessary to obtain biopsy samples using an endoscopic toolwhich is inserted into a body cavity through a trocar tube or directlyinto a body cavity. These procedures typically involve the taking oftissue samples from the cervix. Many of the problems facing the"flexible" biopsy forceps which are used in an endoscope are not presentin the gynecological biopsy procedure. Nevertheless, it is still oftennecessary or desirable to take multiple cervical samples and therepeated insertion and withdrawal of the bioptome prolongs the procedureand increases the trauma to the patient.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide an endoscopicmultiple sample bioptome which is not limited to lateral tissuesampling.

It is also an object of the invention to provide an endoscopic multiplesample bioptome which is easy to operate.

It is another object of the invention to provide an endoscopic multiplesample bioptome which is inexpensive to manufacture.

It is still another object of the invention to provide an endoscopicmultiple sample bioptome which has all of the advantages of traditionalbiopsy forceps with the added ability to collect multiple samples.

In accord with these objects which will be discussed in detail below,the endoscopic multiple sample bioptome of the present inventionincludes a relatively long flexible member having a lumen with anaxially displaceable wire extending therethrough. The proximal ends ofthe flexible member and wire are coupled to a manual actuation means foraxially displacing one of the flexible member and wire relative to theother. The distal end of the flexible member is coupled to one of acylinder having a knife sharp distal edge and a jaw assembly. The distalend of the wire is coupled to the other of the cylinder and the jawassembly. The jaw assembly includes a pair of opposed toothed jaw cupseach of which is coupled by a narrow arm to a base member. The narrowarm of each jaw is a resilient member which urges each jaw away from theother. The base member of the jaw assembly is mounted inside thecylinder and axial movement of one of the jaw assembly and cylinderrelative to the other draws the necks of the jaws into the cylinder ormoves the cylinder over the necks of the jaws to bring the jaw cupstogether in a biting action.

Preferred aspects of the invention include: forming the jaw assemblyfrom a single piece of spring steel; coupling the distal end of the coilto the jaw assembly; coupling the cylinder to the axially displaceablewire; and providing the coil with a stiffening sheath or wire alongsubstantially its entire length. It is additionally preferred that thedistal end of the wire be coupled to the cylinder by welding, but othermeans such as a Z-bend in the distal end of the wire which enters andengages a punched and bent portion of the cylinder wall may be used.

According to another embodiment of the invention, an endoscopic multiplesample bioptome is provided with a relatively rigid hollow tube having arelatively rigid rod extending therethrough. The distal end of the rodis coupled to a jaw assembly and the distal end of the tube is providedwith a knife-sharp edge. The proximal end of the rod is coupled to afixed portion of a handle and the proximal end of the tube is coupled toa movable portion of the handle. Movement of the movable portion of thehandle results in longitudinal movement of the tube relative to the rodand effects and closing of the jaws as described above. The fixedportion of the handle is preferably provided with a thumb ring and themovable portion of the handle is preferably provided with a finger ring.The handle is gripped in pistol-like manner and squeezing the movableportion towards the fixed portion effects a closing of the jaws.

According to yet another embodiment of the invention, the jaw assemblyis formed from a single cylindrical piece of spring steel having asubstantially hemispherical end. The cylinder is cut by wire EDM(electrical discharge machining) and/or laser machining to provide alower jaw having a larger jaw cup than the upper jaw. The lower jaw isalso provided with a pair of proximally extending wings. The jaw teethare preferably formed so that they are as small as possible but with theproximal teeth having greater clearance than the distal teeth, e.g. byproviding the proximal teeth with a sharper angle than the distal teeth.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view in partial section of the proximal endof a first embodiment of the invention;

FIG. 2 is an enlarged transparent side elevation view of the distal endof a first embodiment of the invention with the jaws open;

FIG. 3 is an enlarged transparent top view of the distal end of a firstembodiment of the invention;

FIG. 4 is a view similar to FIG. 2, but with the jaws closed;

FIGS. 5a through 5e are views similar to FIGS. 2 and 4 showing asequence of biopsy sampling operations;

FIGS. 5f and 5h are views similar to FIG. 3 showing the cutting actionof the knife-sharp distal edge of the cylinder;

FIG. 6 is a view similar to FIG. 1 of the proximal end of a secondembodiment of the invention;

FIG. 7 is a view similar to FIG. 2 of the distal end of a secondembodiment of the invention with the jaws open;

FIG. 8 is a view similar to FIG. 7, but with the jaws closed;

FIG. 9 is an enlarged top plan view of a sheet of punched steel which isrolled to form the jaw assembly of the invention;

FIG. 10a is an enlarged broken side elevation view of a differentembodiment of control wire coupling;

FIG. 10b is a cross sectional view along line B--B in FIG. 10a;

FIG. 11a is a view similar to FIG. 10a but of yet another embodiment ofcontrol wire coupling;

FIG. 11b is a cross sectional view along line B--B of FIG. 11a;

FIG. 12 is a broken side elevation view in partial section of thirdembodiment of the invention;

FIG. 13 is a side elevation view of a different embodiment of the jawassembly;

FIG. 13a is a cross sectional view along line A--A in FIG. 13; and

FIG. 13b is a cross sectional view along line B--B in FIG. 13.

FIG. 13c is a side elevation view of the embodiment of FIG. 13 in anopen position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 through 4, a first embodiment of the multiplesample bioptome 10 includes a proximal handle 12 and a distal endeffector 14. A long flexible coil 16 having an axially displaceablecontrol wire 18 extending therethrough couples the handle 12 and the endeffector 14. The coil 16 is preferably covered with a PTFE, FEP orpolyolefin sheath 15 along substantially all of its length and a strainrelief sleeve 17 covering a portion of the coil which extends from thehandle 12. The control wire 18 is preferably flexible but longitudinallyinelastic and is ideally formed from 304 Steel and provided with andouter diameter of approximately 0.018 inch. The proximal handle 12includes a central shaft 20 and a displaceable spool 22. The proximalend of the shaft 20 is provided with a thumb ring 24 and a longitudinalbore 26 is provided at the distal end of the shaft 20. A longitudinalslot 28 extends from the proximal end of bore 26 to a point distal ofthe thumb ring 24. The displaceable spool 22 is provided with a crossmember 30 which passes through the slot 28 in the central shaft 20. Thecross member 30 is provided with a central through hole 32 and aradially engaging set screw 34. According to the first embodiment of theinvention, a short bore 36 and a radially engaging set screw 38 areprovided in the shaft 20 distal of the thumb ring 24 with the bore 36communicating with the longitudinal slot 28. In the first embodiment ofthe invention, the proximal end of the coil 16 extends into the centralthrough hole 32 in the cross member 30 and is fixed there by the setscrew 34. The proximal end of the control wire 18, passes through slot28, is inserted into the short bore 36, and held there by the set screw38. From the foregoing, those skilled in the art will appreciate thatrelative movement of the shaft 20 and spool 22 results in movement ofthe control wire 18 relative to the coil 16. Such action results inactuation of the end effector 14 as described in detail below.

Turning now to FIGS. 2 through 4, the end effector 14 includes acylindrical sleeve 40 having a knife-sharp distal edge 42, and a jawassembly 44. The jaw assembly 44 includes a pair of opposed jaw cups46a, 46b each preferably having a plurality of sharp teeth 48a, 48b. Aresilient, preferably narrow, arm 50a, 50b extends proximally from eachjaw cup 46a, 46b. A cylindrical base member 52 joins the proximal endsof the arms 50a, 50b. Because the arms 50a, 50b and the jaws 46a, 46bare preferably formed from a deep drawn piece of spring steel asdiscussed in more detail below, as seen best in FIG. 2, the narrowresilient arms 50a, 50b may be bent apart from each other, therebyurging the jaw cups 46a, 46b apart. According to the first embodiment ofthe invention, the cylindrical base member 52 is coupled to the distalend of the flexible coil 16 by welding, soldering, crimping, or anyother suitable manner. The cylindrical sleeve 40 is coupled to thedistal end of the control wire 18 by providing the sleeve 40 with alateral hole which engages a bent end 18a of the control wire 18. Asshown in FIGS. 2 through 4, the bent end 18a of the control wire 18 iswelded to the hole 45 in the side of the sleeve 40. However, as will bedescribed in detail herein below, other methods of coupling the controlwire to the sleeve are possible. The cylindrical sleeve 40 is slidablymounted over the cylindrical base member 52 as shown in FIGS. 2 and 3and is axially movable over the resilient arms 50a, 50b as shown in FIG.4.

As seen in FIG. 3, the jaw cups 46a, 46b have an eccentric cross sectionwith their widest point indicated by the line 47. Distal of the line 47,the jaw cups are substantially hemispherical and proximal of the line47, the jaw cups are substantially hemi-elliptical. The teeth 48a, 48bare arranged so that the jaws interlock when closed as shown in FIG. 4.If the jaws are formed by wire EDM, teeth are formed only on the sidesof the jaws. If the jaws are formed by laser cutting, however, it ispossible to arrange the teeth radially along the sides and the front ofthe jaws. It will also be seen that the side walls of the jaw cups 46a,46b taper towards the arms 50a, 50b to provide a smooth transition fromthe jaw cups to the arms.

From the foregoing description and with reference to FIGS. 1 through 4,those skilled in the art will appreciate that when the spool 22 and theshaft 20 are axially displaced relative to each other, the cylindricalsleeve 40 and the jaw assembly 44 are similarly axially displacedrelative to each other, from the positions shown in FIG. 2 to thepositions shown in FIG. 4 and vice versa. It will also be appreciatedthat when the spool 22 and shaft 20 are in the approximate positionshown in FIG. 1, the cylindrical sleeve 40 and the jaw assembly 44 willbe in the approximate position shown in FIG. 2; i.e., with the jawsopen. Thus, those skilled in the art will further appreciate that whenthe spool 22 is moved towards the thumb ring 24, or vice versa, thecylindrical sleeve 40 and the jaw assembly 44 will be brought into theapproximate position shown in FIG. 4; i.e., with the jaws closed.Moreover, it will also be appreciated that it is preferable to move thethumb ring 24 relative to the spool 22, rather than vice versa sincethat will move the cylindrical sleeve 40 relative to the jaw assembly 44rather than vice versa. This is desirable so that the jaw assembly isnot moved away from a tissue sample while the jaws are being closed.

Turning now to FIGS. 5a through 5e, the operation of the multiple samplebioptome of the invention is illustrated schematically in sequence. Asseen in FIG. 5a, a first tissue sample is taken by positioning the jawcups 46a, 46b around a tissue 60 to be sampled. The handle of thebioptome is operated as described above so that the cylindrical sleeve40 is moved distally over the narrow arms 50a, 50b of the jaw assembly44 to the position approximately shown in FIG. 5b. When the sleeve 40 ismoved toward this position, the jaw cups 46a, 46b are brought close toeach other and the teeth 48a, 48b of the jaw cups 46a, 46b engage thetissue 60 and bite into it. Contemporaneously, and as seen withreference to FIGS. 5f-5h, the knife sharp edge 42 of the sleeve 40severs any tissue 60 extending from the lateral sides of the jaw cups46a, 46b. A first sample 60a of the tissue 60 is thereby trapped betweenthe jaw cups 46a, 46b and severed from the tissue 60. It should be notedthat while taking the bite, the coil 16 is not free to stretch, as it iskept longitudinally stiff by the shrink wrap or sheath 15 which extendsalong the length of the coil. If desired, a wire can be used instead ofthe shrink wrap or sheath. The wire, which would typically be flat,would be attached to the proximal and distal ends of the coil to keepthe coil in tension and prevent it from stretching as the sleeve ismoved forward and a bite taken.

With the end effector 14 in the position approximately shown in FIG. 5b,the multiple sample bioptome may be relocated to another tissue area forsampling. The handle of the bioptome is operated as described above sothat the cylindrical sleeve 40 is moved proximally over the narrow arms50a, 50b of the jaw assembly 44 to the position approximately shown inFIG. 5c. When the sleeve 40 is moved towards this position, the jaw cups46a, 46b are biased apart by the resilience of their respective arms50a, 50b. The jaw cups can then be positioned around a second tissue 61for sampling. The procedure described above with reference to FIGS. 5aand 5b is repeated. In this instance, however, as the jaw cups 46a, 46bare brought into position, the tissue 61 pushes the first sample 60aproximally away from the jaw cups 46a, 46b and into the space betweenthe narrow arms 50a, 50b as seen in FIG. 5c. Those skilled in the artwill appreciate that the tissue sample 60a is typically gummy and pliantand will stick to and move along one or both of the narrow arms 50a, 50bof the jaw assembly 44. The samples will also stick to each other. Uponthe taking of a sample 61a from the tissue 61, both samples 60a and 61aare safely trapped between the narrow arms 50a, 50b of the jaw assembly44 as shown in FIG. 5d. The procedure described above with reference toFIGS. 5a through 5d is then repeated as suggested in FIG. 5e until thespace between the arms 50a, 50b is filled with samples 60a, 61a, etc.According to a presently preferred embodiment of the invention, sixsamples may be captured between the arms of the jaw assembly. Thepresently preferred dimensions of the jaw assembly are approximately0.45 inch long by approximately 0.095 outer diameter.

FIGS. 5f-5h show a top view of the sequence of operations depicted inside views in FIGS. 5a and 5b. From the top view of FIG. 5f, it can beseen that the tissue 60 extends beyond the sides of the jaw cups 46a,46b. The knife-sharp distal edge 42 of the cylinder 40 trims the tissue60 which extends beyond the jaw cups to completely sever the sample 60afrom the tissue 60 as shown in FIGS. 5g and 5h.

A second embodiment of the invention is shown FIGS. 6 through 8. In thisembodiment, a proximal handle 112 and a distal end effector 114 arecoupled by a long flexible coil 16 having an axially displaceablecontrol wire 18 extending therethrough. The proximal handle 112 includesa central shaft 120 and a displaceable spool 122. The proximal end ofthe shaft 120 is provided with a thumb ring 124 and a steppedlongitudinal bore 126 is provided at the distal end of the shaft 120. Alongitudinal slot 128 extends from the proximal end of bore 126 to apoint distal of the thumb ring 124. The displaceable spool 122 isprovided with a cross member 130 which passes through the slot 128 inthe central shaft 120. The cross member 130 is provided with a centralhole 132 and a radially engaging set screw 134. According to this secondembodiment of the invention, the proximal end of the coil 16 is fixedlymounted in the longitudinal bore 126 and the proximal end of the controlwire 18 extends into the central hole 132 in the cross member 130 and isfixed there by the set screw 134. From the foregoing, those skilled inthe art will appreciate that movement of the shaft 120 relative to thespool 122 results in movement of the control wire 18 relative to thecoil 16. Such action results in actuation of the end effector 114 asdescribed in detail below.

As seen in FIGS. 7 and 8, the end effector 114 according to the secondembodiment of the invention includes a cylindrical sleeve 140 having aknife-sharp distal edge 142 and a jaw assembly 144. The jaw assembly 144includes a pair of opposed jaw cups 146a, 146b each having a pluralityof sharp teeth 148a, 148b. A resilient, preferably narrow arm 150a, 150bextends proximally from each jaw cup 146a, 146b. A cylindrical basemember 152 joins the proximal ends of the arms 150a, 150b. As seen bestin FIG. 7, the narrow resilient arms 150a, 150b are bent apart from eachother urging the jaw cups 146a, 146b apart. According to the secondembodiment of the invention, the proximal end of the cylindrical sleeve140 is coupled to the distal end of the flexible coil 16 by welding,soldering, crimping, or any other suitable manner. The cylindrical basemember 152 of the jaw assembly 144 is coupled to the distal end of thecontrol wire 18 by providing the base member 152 with a lateral hole 154which engages a bent end 18a of the control wire 18 in a manner similarto that shown in FIG. 3 in the description of the first embodiment ofthe invention. However, as will be described in detail herein below,other methods of coupling the control wire to the base member arepossible. The base member 152 and thus the entire jaw assembly 144 isslidably mounted and axially movable within the cylindrical sleeve 140as shown in FIGS. 7 and 8. Those skilled in the art will appreciate thatthis second embodiment of the invention is quite similar to the firstembodiment described above except that the sleeve 140 is coupled to thecoil 16 which is coupled to the central shaft 120 of the handle 112 andthe jaw assembly 144 is coupled to the control wire 18 which is coupledto the spool 122. Operation of this embodiment is substantially the sameas the first embodiment described above.

The jaws 44, 144 of the multiple sample bioptome of the invention may beformed in different ways. According to the presently preferredembodiment, a cylinder of 304 or 17-7 stainless spring steel preferablyhaving a diameter just slightly smaller than the diameter of the sleeve40, 140 is deep drawn to provide an enclosed hemispherical bottom. Thebottom of the cylinder is then cut using wire electrical dischargemachining (EDM) and/or laser machining. Preferably, reciprocal teeth arecut into the periphery of the cylinder bottom, thereby forming theopposed jaw cups. However, even if no teeth are formed, the opposed jawcups are provided with sharp cutting surfaces. Continuing away from thedistal jaw cups, the arms are formed by tapering up a cutout of anapproximately 100-135 degree section on two sides leaving arms whicheach extend about 45-80 degrees around the periphery of the cylinder.The so-formed jaws are then bent away from each other to providepre-loaded springy arms (i.e., leaf spring beams) which can be closed bythe sleeve 40, 140 as described above.

According to another embodiment of the invention, the jaw assembly 44,144 of either the first or the second embodiment may be formed from asingle sheet of 0.005 inch thick 304, 17-7 steel which is cut androlled. FIG. 9 shows a plan view of a steel sheet 244 which has been cutto form the base member 252, the narrow arms 250a, 250b, the jaw cups246a, 246b and the jaw cup teeth 248a, 248b. Those skilled in the artwill appreciate that the cutting of the sheet 244 may be accomplished inseveral ways, although photochemical milling (PCM) is preferred. Tofacilitate automation in PCM, indexing holes 251a, 251b are provided inthe base member portion of the sheet 244. These holes are used to alignthe strip of PCM cutters in the progressive forming dies. After thesheet is cut, it is pressed and rolled to form an integral unitary jawassembly as shown in FIGS. 2-4, 7 and 8.

As mentioned herein above, there are several ways in which the distalend 18a of the control wire 18 may be coupled to the cylindrical sleeve40 or the base member 152 of the jaw assembly 144. While welding is thepresently preferred method, FIGS. 10a through 11b show two other methodsof coupling the distal end of the control wire 18 with either the sleeveor the jaw assembly.

As shown in FIGS. 10a and 10b, the distal end 18a of the control wire 18is provided with a Z-bend. The side wall of the cylindrical sleeve 40 orthe base member 152 is punched with two spaced apart semicircular holes145a, 145b leaving a bendable narrow strip 145c between them. The narrowstrip 145c is bent radially inward a distance sufficient to accommodatethe distal end 18a of the control wire 18. The Z-bend of the distal end18a of the control wire 18 is inserted through the space formed betweenthe narrow strip 145c and the semicircular holes 145a, 145b as shown inFIGS. 10a and 10b.

As shown in FIGS. 11a, and 11b, the side wall of the cylindrical sleeve40 or the base member 152 is punched with a first hole 245a and a secondhole 245c which is circumscribed by the first hole 245a. The first hole245a is preferably rectangular, semicircular, or trapezoidal in shape toform a bendable tab 245b which is bent radially inward as shown best inFIG. 11b. The Z-bend of the distal end 18a of the control wire 18 isinserted through the second hole 245c in the bendable tab 245b as shownin FIGS. 11a and 11b.

FIG. 12 shows another embodiment of a multiple sample bioptome 310 ofthe invention which is particularly suited for cervical biopsyprocedures or other biopsy procedures where the biopsy site isapproachable in a relatively short and direct path rather than throughthe long tortuous path of the lumen of an endoscope. In this embodiment,a proximal handle 312 is provided with a fixed portion 324 and a movablelever portion 322 which is coupled to the fixed portion by a pivot pin323. A hollow tube 340 is coupled at its proximal end to the movablelever portion 322 of the handle 312 by a cross pin 341 or other suitablefastening means. A relatively rigid rod 318 extends through the tube 340and is coupled at its proximal end to the fixed portion 324 of thehandle 312 by means of a cross pin 319 or other suitable fasteningmeans. The distal end of the tube 340 is provided with a knife sharpedge 342 and the distal end of the rod 318 is coupled to a jaw assembly344 as described herein above. As shown in FIG. 12, the fixed portion324 is provided with a lower thumb ring 324a and the movable leverportion 322 is provided with a lower finger ring 322a. The upper end322b of the movable lever portion 322 is provided with a slot 322c forengaging the cross pin 341 and the rod 318 is provided with a slot 317through which the cross pin passes. Those skilled in the art willappreciate that the handle 312 is manipulated using a conventionhand-grip. Pivotal movement of the movable lever portion 322 of thehandle 312 as indicated by the arrows 321 results in linear movement ofthe tube 340 as indicated by the arrows 339. It will also be appreciatedthat the slots 317 and 322c may be dimensioned to limit movement of thetube 340. Movement of the tube 340 relative to the rod 318 results inopening and closing of the jaw assembly 344 as described herein above.The handle 312 described above may be used with the flexible coil andpull wire described with reference to FIGS. 1 and 2 and conversely, thehandle 12 described with reference to FIG. 1 may be used with the tubeand rod arrangement described above with reference to FIG. 12.

It will be appreciated that all of the embodiments of the multiplesample bioptome shown in FIGS. 1-12 can be provided with a cauterycapability. For example, as seen in FIG. 12, a cautery contact 398 isprovided which contacts the rigid rod 318 and extends out of the fixedportion 324 of the handle 312. In addition, the tube 340 is providedwith shrink wrap or other insulation 399. With the provided arrangement,when a cautery current is applied to the cautery contact 398, the jawassembly 344 is electrified via its connection to the rod 318.Typically, cauterization would be carried out after a sample is obtainedand severed from the surgical site with the jaws still located at thesurgical site. Because the body of the patient acts as the secondelectrode (ground), current flows from the jaws into the patient at thesurgical site, thereby effecting a cauterization of the surgical siterather than cauterizing the sample in the jaws.

FIG. 13 shows another embodiment of a jaw assembly 444. The jaw assembly444 is preferably formed from an oblate spring steel cylinder 443 havinga substantially hemispherical distal end 445 an somewhat flattened sides441, 442. The cylinder 443 is cut using wire EDM or laser machiningalong a zigzag line 448 from the distal end 445 to form jaw teeth 448a,448b and then along an upwardly inclined line 449 to form the jaw cups446a, 446b. A substantially C-shaped cut 450 forms the arms 450a, 450bwhich extend from the base portion 452 to the jaw cups 446a, 446b. It ispreferred that the arms 450a, 450b be as long as possible so that thejaws can be spread sufficiently far apart. In the presently preferredembodiment, the arms extend approximately 0.5-0.6 inch from the baseportion to the jaw cups. The cut lines 448 and 449 are axially offset sothat the lower jaw cup 446b is larger than the upper jaw cup 446a asseen best in FIG. 13b. In addition, another substantially C-shaped cut451 is made at the proximal end of the lower jaw cup 446b to form twowings 453, 454 which are seen best in FIG. 13a. After forming the jawassembly 444, the arms 450a, 450b are bent apart as shown in FIG. 13c.The spring steel from which the jaw assembly was formed maintains thisspread apart position with resilience so that the jaws can be squeezedtogether to the position shown in FIG. 13 and spring apart to theposition shown in FIG. 13c. According to a presently preferredembodiment, the jaw cups are bent approximately 0.25 inch apart, thenclosed and opened several times until the resulting opening is about0.18 inch. The upper edges 446c, 446d of the lower jaw cup 446b are bentslightly inward as shown in FIG. 13b so that they are embraced by theupper jaw cup 446a when the jaws are closed. Similarly, the wings 453,454 are bent radially inward as shown in FIG. 13a. The jaw assembly 444can be used with any of the bioptome embodiments described above.

The jaw assembly 444 described above provides several importantadvantages. The oblate sides 441, 442 of the cylinder 443 help the teeth448a, 448b to mesh without gaps. The long arms 450a, 450b allow for awide opening of the jaws and for locating the spring area in the arms asufficient distance from the distal end of the jaws so that the bendingmoments on the arms is low enough to avoid plastic deformation. Thewings 453, 454 stabilize the jaws against rotation during opening andclosing and also protect biopsy samples in several ways. The wings forma storage chamber 455 (FIG. 13a) which extends proximally from the lowerjaw cup 446b and prevents accumulated biopsy samples from being squeezedlaterally out from between the jaws during repeated opening and closingand protects them from being repeatedly trimmed by the sharp edge of thesliding tube. The larger lower jaw cup 446b enhances movement of biopsysamples into the storage chamber 455.

There have been described and illustrated herein several embodiments ofan endoscopic multiple sample bioptome. While particular embodiments ofthe invention have been described, it is not intended that the inventionbe limited thereto, as it is intended that the invention be as broad inscope as the art will allow and that the specification be read likewise.Thus, while particular configurations of the handle have been disclosed,it will be appreciated that other types of handles could be utilized.Also, while specific couplings of the ends of the coil and control wirehave been shown, it will be recognized that other types of couplingscould be used with similar results obtained. Similarly, while specificcouplings of the ends of the rigid tube and rod have been shown, it willbe understood that other types of couplings could be used. Moreover,while particular configurations have been disclosed in reference to thejaw assembly, it will be appreciated that other configurations could beused as well. For example, while it is preferred to provide jaws withteeth, it will be appreciated that in lieu of teeth, the jaws can beprovided with sharp edges which, in conjunction with the sharp cylinder,will provide a cutting ability. Furthermore, while the jaw assembly hasbeen disclosed as being formed from a single piece of spring steel, itwill be understood that different formations of the jaw assembly canachieve the same or similar function as disclosed herein. Further yet,it will be appreciated that while the apparatus of the invention wasdescribed as advantageously permitting the obtaining of multiplebiopsies without removal from the surgical site, the apparatus of theinvention, if desired, could still be used for obtaining single biopsiesat a time. It will therefore be appreciated by those skilled in the artthat yet other modifications could be made to the provided inventionwithout deviating from its spirit and scope as so claimed.

We claim:
 1. An endoscopic bioptome, comprising:a) a hollow outer memberhaving a proximal and a distal end; b) an inner control member having aproximal and a distal end and extending through said hollow outermember; c) a cylinder coupled to said distal end of one of said hollowouter member and said inner control member; d) a jaw assembly includinga base member and pair of resilient arms extending distally from saidbase member, each of said resilient arms terminating in a jaw cup saidbase member being coupled to said distal end of the other of said hollowouter member and said inner control member; and e) actuation meanscoupled to said proximal end of said hollow outer member and to saidproximal end of said inner control member for axially displacing one ofsaid hollow outer member and said inner control member relative to theother of said hollow outer member and said inner control member,thereby-said cylinder extends around said pair of resilient arms, closessaid jaws, thereby effecting a cutting action.
 2. An endoscopic bioptomeaccording to claim 1, wherein:said hollow outer member is a flexiblemember having a lumen and said inner control member is a flexiblecontrol wire.
 3. An endoscopic bioptome according to claim 1,wherein:said hollow outer member and said inner control member are bothsubstantially rigid.
 4. An endoscopic bioptome according to claim 1,wherein:said actuation means includesi) a shaft having a distal bore, aproximal thumb ring, and a central slot, and ii) a displaceable spoolhaving a cross member extending through said central slot.
 5. Anendoscopic bioptome according to claim 4, wherein:said proximal end ofsaid hollow outer member is coupled to said cross member of said spool,and said proximal end of said inner control member is coupled to saidshaft.
 6. An endoscopic bioptome according to claim 4, wherein:saidproximal end of said hollow outer member is coupled to said shaft, andsaid proximal end of said inner control member is coupled to said spool.7. An endoscopic bioptome according to claim 6, wherein:said cylinder iscoupled to said distal end of said hollow outer member, and said basemember of said jaw assembly is coupled to said distal end of said innercontrol member.
 8. An endoscopic bioptome according to claim 7,wherein:said base member has a radial hole and said distal end of saidcontrol member is bent and coupled to said radial hole.
 9. An endoscopicbioptome according to claim 7, wherein:said base member has a radiallyinward extending tab and said distal end of said control member is bentand coupled to said tab.
 10. An endoscopic bioptome according to claim7, wherein:said base member has a radially inward extending strip andsaid distal end of said control member is bent and coupled to saidstrip.
 11. An endoscopic bioptome according to claim 1, wherein:saidresilient arms each includes a curved portion which circumscribes atmost 80 degrees and each jaw is formed as a cup having a sharp edge. 12.An endoscopic bioptome according to claim 11, wherein:one of said cupsis larger than another.
 13. An endoscopic bioptome according to claim12, wherein:the larger of said cups is provided with a pair ofproximally extending wings.
 14. An endoscopic bioptome according toclaim 13, wherein:an upper edge of the larger of said cups is bentradially inward so that it enters the smaller of said cups when saidjaws are closed.
 15. An endoscopic bioptome according to claim 14,wherein:said wings are bent radially inward.
 16. An endoscopic bioptomeaccording to claim 14, wherein:said jaw assembly is formed from a deepdrawn cylinder of steel which is machined by one of electrical dischargemachining and laser cutting.
 17. An endoscopic bioptome according toclaim 16, wherein:said cylinder is oblate with a substantiallyhemispherical end.
 18. An endoscopic bioptome according to claim 11,wherein:said resilient arms are bent apart from each other approximately0.18 to 0.25 inches.
 19. An endoscopic bioptome according to claim 17,wherein:actuation of said actuation means moves one of said jaw assemblyand said cylinder relative to the other so that said resilient arms aresubstantially covered by said cylinder and said jaws are moved towardseach other.
 20. An endoscopic bioptome according to claim 19,wherein:said movement of said one of said jaw assembly and said cylinderrelative to the other is approximately 0.5 to 0.6 inch.
 21. Anendoscopic bioptome according to claim 11, wherein:said jaw assembly isformed from a single sheet of steel which is cut and rolled.
 22. Anendoscopic bioptome according to claim 11, wherein: each said sharp edgecomprises a plurality of teeth.
 23. An endoscopic bioptome according toclaim 1, wherein:said actuation means includesi) a fixed handle having athumb ring, and ii) a movable lever pivotally coupled to said fixedhandle, said movable lever having a finger ring.
 24. An endoscopicbioptome according to claim 23, wherein:said proximal end of said hollowouter member is coupled to said movable lever, and said proximal end ofsaid inner control member is coupled to said fixed handle.
 25. Anendoscopic bioptome according to claim 1, wherein:said cylinder has asharp distal edge.
 26. An endoscopic bioptome, comprising:a) a hollowouter member having a proximal and a distal end; b) an inner controlmember having a proximal and a distal end and extending through saidhollow outer member; c) a cylinder coupled to said distal end of one ofsaid hollow outer member and said inner control member; d) a jawassembly including a base member and a pair of resilient arms extendingdistally from said base member, each of said resilient arms terminatingin a jaw, said base member being coupled to said distal end of the otherof said hollow outer member and said inner control member; and e)actuation means coupled to said proximal end of said hollow outer memberand to said proximal end of said inner control member for axiallydisplacing one of said hollow outer member and said inner control memberrelative to the other of said hollow outer member and said inner controlmember, whereby said cylinder extends around said pair of resilient armsand closes said jaws, wherein,said cylinder is coupled to said distalend of said inner control member, and said base member of said jawassembly is coupled to said distal end of said outer hollow member. 27.An endoscopic bioptome according to claim 26, wherein:said cylinder hasa radial hole and said distal end of said control member is bent andcoupled to said radial hole.
 28. An endoscopic bioptome according toclaim 26, wherein:said cylinder has a radially inward extending tab andsaid distal end of said control member is bent and coupled to said tab.29. An endoscopic bioptome according to claim 26, wherein:said cylinderhas a radially inward extending strip and said distal end of saidcontrol member is bent and coupled to said strip.
 30. An endoscopicbioptome according to claim 26, wherein:said cylinder has a sharp distaledge.
 31. An endoscopic bioptome, comprising:a) a hollow outer memberhaving a proximal and a distal end; b) an inner control member having aproximal and a distal end and extending at least partially through saidhollow outer member; c) a jaw assembly comprising a single integralpiece of metal, said jaw assembly including(i) a substantiallycylindrical base member, (ii) a pair of resilient arms extendingdistally from said base member and bent away from each other, each ofsaid resilient arms including a portion which circumscribes at most 80degrees around a circumference of said cylindrical base member, and(iii) a pair of jaws respectively coupled to distal ends of said pair ofresilient arms, each of said pair of jaws having a sharp edged cuttingsurface, said pair of jaws when said cutting surfaces are closed forminga substantially hemispherical enclosure, d) closure means for movingrelative to said pair of resilient arms and extending over said pair ofresilient arms to close said pair of jaws, said closure means beingcoupled to said distal end of one of said hollow outer member and saidinner control member; and e) actuation means coupled to said proximalend of said hollow outer member and to said proximal end of said innercontrol member for axially displacing one of said hollow outer memberand said inner control member relative to another of said hollow outermember and said inner control member, thereby causing said closure meansto close said pair of jaws, and effect a cutting action.
 32. Anendoscopic bioptome according to claim 31, wherein:one of said jaws islarger than the other, with the larger of said jaws being provided witha pair of proximally extending wings which are bent radially inwardly.33. An endoscopic bioptome according to claim 32, wherein:an upper edgeof the larger of said jaws is bent radially inward so that it enters thesmaller of said jaws when said jaws are closed.
 34. An endoscopicbioptome according to claim 31, wherein:each said sharp edged cuttingsurface comprises a plurality of teeth.
 35. An endoscopic bioptomeaccording to claim 31, wherein:said jaw assembly is formed from a singlesheet of metal which is cut and rolled.
 36. An endoscopic bioptomeaccording to claim 31, wherein:said jaw assembly is formed from a deepdrawn cylinder of metal which is machined by one of electrical dischargemachining and laser cutting.